Statistical Elements of Implementing ICH Quality Guidelines

Description

This 2-day seminar explores the unique challenges facing quality functions of pharmaceutical and biotechnology companies. Attendees will learn practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate risk of poorly designed studies. Participants will learn statistical methods related to ICH guidelines and will discover how regulatory agencies, such as the FDA expect organizations to meet these guidelines.

Areas covered:
Day 1: ICH review and Statistics Fundamentals

Review ICH Quality Guidelines (Q Series)
Q1 Stability Testing
Q2 Analytical Validation
Q3A-3E Impurities
Q4 Pharmacopoeias
Q5A-5E Quality of Biotechnological Products
Q6A-6B Specifications
Q7 Good Manufacturing Practice
Q8 Pharmaceutical Development
Q9 Quality Risk Management
Q10 Pharmaceutical Quality System
Q11 Development and Manufacture of Drug Substances
Q12 Lifecycle Management
Q13 Continuous Manufacturing of Drug Substances and Drub Products
Q14 Analytical Procedure Development
Developing a Quality Risk Management Plan
Fundamentals of Statistics
Normal Distribution
Descriptive and Summary Statistics
Graphical Techniques
Null Hypothesis Statistical Testing
Confidence and Tolerance Intervals
Statistical vs. Meaningful Significance
Day 2: Statistical Tests and Applications to Industry

Statistical Analyses
Comparative Statistics
Regression Analysis
Sample Size (Power Analysis)
Discussion/Questions
Application to Industry
Design of Experiments (DOE)
Setting Specifications/Thresholds/Acceptance Criteria
Stability/Shelf-Life Testing
Assay Validation
Impurities
Discussion/Questions